Voyant Open Fusion Device

Electrosurgical, Cutting & Coagulation & Accessories

APPLIED MEDICAL RESOURCES

The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Voyant Open Fusion Device.

Pre-market Notification Details

Device IDK153288
510k NumberK153288
Device Name:Voyant Open Fusion Device
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactJessica Cho
CorrespondentJessica Cho
APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-13
Decision Date2016-06-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.